FDA: Page 69
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FDA warns of cyanide gas risk with certain media if used with Hologic coronavirus test
The agency alerted clinical labs and healthcare providers to the potential for bleach to react with guanidine materials and produce deadly gas, making it unsafe to use some transport media with Hologic’s assays.
By Nick Paul Taylor • June 5, 2020 -
"White House Press Briefing". Retrieved from The White House.
Months into pandemic, Trump admin mandates labs report demographic data of COVID-19 tests
HHS is now requiring labs to submit a much broader range of data related to testing. However, the American Clinical Laboratory Association said it's difficult for labs to get information to public health agencies without help from providers.
By Rebecca Pifer Parduhn • June 4, 2020 -
Explore the Trendline➔
Permission granted by Boston Scientific
TrendlineNew medical devices are reshaping the medtech industry
From pulsed field ablation devices to glucose sensors and surgical robotics, new medical technologies are transforming patient care and how people manage their health.
By MedTech Dive staff -
European Commission lays out timeline for next steps toward MDR, IVDR
Targets for issuing upcoming implementing acts, including those on reprocessing single-use medical devices and the delayed Eudamed database, range from the coming quarter to two years from now.
By Nick Paul Taylor • June 4, 2020 -
PMA major deficiency letters tick up, 510(k) asks for info flatline: MDUFA report
FDA's second quarter report for fiscal 2020, which covered January through March, also showed that the agency still has many guidance document priorities to check off its list.
By Maria Rachal • June 4, 2020 -
CMS relaxes more value-based model rules in wake of pandemic
Payments and reporting rules related to joint replacements, end stage renal disease and diabetes care were among those addressed.
By Shannon Muchmore • June 3, 2020 -
Jacob Bell/MedTech Dive
Fitbit, NASA get latest FDA emergency authorizations for ventilators
Fitbit's invention is considered an emergency resuscitator, the same label given to a device manufactured by Boston Scientific. NASA's breathing machine builds on a version of a full-fledged ventilator that gained FDA's OK in April.
By Nick Paul Taylor • June 3, 2020 -
Four deaths trigger Class I recall for parts of Medtronic's HeartWare system
The FDA issued the safety alert Thursday, its second in quick succession. The ventricular assist device has been the subject of more than a dozen such high-risk recall notices since 2014.
By Nick Paul Taylor • May 29, 2020 -
EU group sets path for pre-MDR notified body renewal, coronavirus-era surveillance
A new guidance applies to designating authorities and medical device sector notified bodies whose designations would have expired between this week and the Medical Device Regulation's delayed go-live date next May.
By Maria Rachal • May 28, 2020 -
Emergency authorization granted to COVID-19 ICU prediction software
The FDA nod for CLEW Medical's system is among a series of regulatory OKs for products designed to inform care for infected patients.
By Nick Paul Taylor • May 28, 2020 -
Jacob Bell/MedTech Dive
FDA offers reference panel to validate coronavirus tests amid false negatives
The aim is to aid commercial and lab developers in ensuring diagnostic testing quality with independent performance validation. Recent studies flagged double-digit rates of false negatives among such tests.
By Nick Paul Taylor • May 28, 2020 -
FDA Breakthrough Devices Program nears 300 designations
The agency has tapped 50 devices so far this year, with recent nods to Orteq, Thermedical, ArcherDX, Helius, PhotoPharmics and Terumo.
By Susan Kelly • May 27, 2020 -
CDC seeks to limit false positives with COVID-19 antibody testing, as immunity question lingers
The interim guidelines promote using high-specificity assays and conducting confirmatory tests when appropriate. However, the agency won't yet use serologic test results to sway public health recommendations.
By Nick Paul Taylor • May 27, 2020 -
FDA eases rules on changes to PMA, HDE devices to avoid coronavirus supply disruptions
Companies that market medical devices under premarket approvals or humanitarian device exemptions can make limited modifications to design and production without giving prior notice, according to special guidance.
By Nick Paul Taylor • May 22, 2020 -
Abbott, Roche ink deals with UK for 10M coronavirus antibody tests
The notice from the government, which bought $20 million in unreliable antibody tests early in the crisis, came as FDA removed 28 products from a list of the tests that can be used without emergency use authorizations.
By Nick Paul Taylor • May 22, 2020 -
Hospitals push FEMA to form broad supply pact with medtech
The agency on Thursday is set to discuss a proposed five-year voluntary agreement with industry to better distribute medical products, which health systems hope will go beyond personal protective equipment.
By Nick Paul Taylor • Updated May 26, 2020 -
COVID-19 drives EC to change rules on notified body designations
The European Commission is allowing certain deviations from normal procedures governing notified bodies, enabling renewal of designations under the outgoing device regulations without performing on-site assessments.
By Nick Paul Taylor • May 20, 2020 -
Labs welcome CMS rate for coronavirus antibody testing
Analysts at William Blair said the roughly $42 rate for common serological tests is higher than expected, which may bode well for antigen testing reimbursement.
By Nick Paul Taylor • May 20, 2020 -
Jacob Bell/MedTech Dive
FDA OKs 1st at-home collection kit for use with multiple labs, coronavirus tests
The emergency use authorization to Everlywell follows earlier nods to LabCorp and Rutgers Clinical Genomics Laboratory for at-home specimen collection for analysis solely at their own labs.
By Nick Paul Taylor • May 18, 2020 -
Allergan's breast implant postmarket studies 'unacceptable,' FDA warns
Within the last 14 months, every manufacturer of the controversial devices allowed for sale in the U.S. has received a warning letter from the agency.
By Maria Rachal • May 15, 2020 -
FDA revokes umbrella EUA for infusion pumps due to lack of industry use
The agency told medtechs it may instead grant individual EUAs for the devices going forward. B. Braun contends it is the only company with such an emergency authorization and is not affected by the revocation.
By Greg Slabodkin • Updated Sept. 24, 2020 -
Cardiology group ranks best devices for aorto-iliac arterial interventions
The Society for Cardiovascular Angiography and Interventions detailed stances on several key issues, including endovascular device effectiveness, issued Thursday at its virtual conference.
By Nick Paul Taylor • May 15, 2020 -
Courtesy of Caption Health, PRNewswire
Philips, startups look to deploy new ultrasound tech amid coronavirus
The need for point-of-care imaging for lung and cardiac complications among COVID-19 patients has led to a flurry of expedited FDA reviews.
By Nick Paul Taylor • May 14, 2020 -
EC outlines clinical trial safety reporting between MDR, Eudamed start dates
Even with the recent delay to the date of application of the Medical Device Regulation, there will still be at least a 12-month period when the key Eudamed database is not fully available.
By Nick Paul Taylor • May 14, 2020 -
House Dems carve out $75B for coronavirus testing, contact tracing in bid for new relief package
The $3 trillion bill passed the House by a vote of 208-199 on Friday. It's Democrats' opening gambit for the next wave of congressional action, but Republicans say they're not in a hurry to approve new funding.
By Susan Kelly • Updated May 18, 2020 -
FDA flags 2nd high-risk recall of embolectomy catheters in recent weeks
The potential for a detached catheter tip to damage blood vessels and cause serious injuries or death underpinned the agency’s Class I label for an Applied Medical recall on Tuesday, seven months after the company initiated the recall.
By Nick Paul Taylor • May 13, 2020
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